BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEAK FX PLATE 3 HOLE NS

    MDR report key: 1061364 · Received June 13, 2008

    Report

    Report Number
    1818910-2008-02254
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    KTT
    PMA / PMN Number
    K063509
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PT HAS A FRACTURED PLATE. SURGEON DECIDED NOT TO REVISE BECAUSE OF EVIDENCE OF HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEAK FX PLATE 3 HOLE NS 87KTT KTT DEPUY ACE S.A. 'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA